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9,360 catalysts · 3,189 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 584 earnings

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  • 8k filing3,189
  • grant2,032
  • device adverse event1,000
  • approval910
  • device 510k674
  • earnings584
device pma
508
  • device recall215
  • phase 2 completion172
  • recall167
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    • Oncology148
    • Infectious Disease46
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    • Pain15

    Week of Feb 9, 2026

    50
    ›Feb 12, 2026grant182d agoUNIVERSITY OF MINNESOTA — Differentiation and characteristics of Helios+ CD8+ T cellsUniversity of Minnesota

    AI grant. $407,326. PI: STEPHEN C JAMESON

    full page →nih reporter ↗
    ›Feb 12, 2026grant182d agoRUTGERS THE STATE UNIV OF NJ CAMDEN — In vivo platforms for exploring co-evolution of ligands, receptors, and their...

    GM grant. $423,734. PI: Nir Yakoby

    full page →nih reporter ↗
    ›Feb 13, 2026approval181d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

    Sponsor: ZYDUS LIFESCIENCES. Form: GEL. Route: TOPICAL

    full page →METRONIDAZOLE →fda approvals ↗
    ›Feb 13, 2026approval181d agoAVOPEF (ETOPOSIDE) — FDA approvaletoposide

    Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAVENOUS

    full page →etoposide →fda approvals ↗
    ›Feb 13, 2026approval181d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

    Sponsor: HQ SPCLT PHARMA. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

    Sponsor: HARMONY. Form: TABLET. Route: ORAL

    full page →pitolisant hydrochloride →fda approvals ↗
    ›Feb 13, 2026approval181d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: UNICHEM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: UNICHEM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoAMMONIA N 13 (AMMONIA N-13) — FDA approval

    Sponsor: WA UNIV SCH MED. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoRYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ) — FDA approval(amivantamab + hyaluronidase (human recombinant))

    Sponsor: JANSSEN BIOTECH. Form: VIAL. Route: SINGLE-USE

    full page →(amivantamab + hyaluronidase (human recombinant)) →fda approvals ↗
    ›Feb 13, 2026approval181d agoGADAVIST (GADOBUTROL) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

    Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 13, 2026approval181d agoCOLCHICINE — FDA approvalCOLCHICINE

    Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

    full page →COLCHICINE →fda approvals ↗
    ›Feb 13, 2026device 510k181d agoShenzhen Best Electronics Co., Ltd. — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) (510k cleared)

    Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoClouds of Care — PreOp v3 (510k cleared)

    Product code: OLX. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model W2) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoABBOTT MEDICAL — Armada™ 14 NC PTA Catheter (510k cleared)

    Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoEndo Tools Therapeutics S.A. — Endomina EZFuse system (510k cleared)

    Product code: OCW. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoAlcon Laboratories, Inc. — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (510k cleared)Alcon Laboratories Inc

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoLex Diagnostics Limited — VELO Respiratory Test (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoRetia Medical Systems, Inc. — Argos Infinity (Rev. 1.0) (510k cleared)MERIT MEDICAL SYSTEMS INC

    Product code: DXG. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoNanoHive Medical, LLC — Hive™ Standalone Cervical System and Hive™ C Interbody System (510k cleared)

    Product code: ODP. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoShenzhen Imdk Medical Technology Co., Ltd. — Wrist Blood Pressure Monitor (BPM-W1VL) (510k cleared)NewBay Medical Technology Co Ltd

    Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoShanghai United Imaging Healthcare Co., Ltd. — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (510k cleared)

    Product code: KPS. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model W12) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoPulmonx Corporation — Chartis Precision Catheter (510k cleared)Pulmonx Corp

    Product code: CBI. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoMedinice S.A. — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (510k cleared)

    Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoContour Research, LLC — Contour Light (CL-100) (510k cleared)

    Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (510k cleared)NVP Healthcare Co Ltd

    Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoMedela, LLC — Motion InBra (YM-8801) wearable breast pump (510k cleared)

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoDrägerwerk AG & Co. KGaA — Babyleo TN500 (510k cleared)

    Product code: FMZ. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoMeasure Labs, Inc. (Dba Preemptiveai, Inc.) — PreemptiveAI Clinical SDK (510k cleared)

    Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoShenzhen Hingmed Medical Instrument Co., Ltd. — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (510k cleared)

    Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoVPIX Medical, Inc. — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (510k cleared)VYCOR MEDICAL INC

    Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoMerit Medical Systems, Inc. — STAR RF Ablation System (510k cleared)MERIT MEDICAL SYSTEMS INC

    Product code: GXI. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoBayer Medical Care, Inc. — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (510k cleared)

    Product code: DXT. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k181d agoArbor Endovascular, LLC — Willow 18 Guidewire (510k cleared)

    Product code: MOF. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Feb 13, 2026device pma181d agoBoston Scientific Corp — ACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoBoston Scientific — RELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoMedtronic, Inc. — Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoMedtronic Sofamor Danek USA, Inc. — Infuse Bone Graft (PMA supplement)Medtronic USA Inc

    Supplement type: Panel Track. Product code: NEK. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: MOM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)DFB Soria LLC

    Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoABBOTT MEDICAL — Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoABBOTT MEDICAL — Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 13, 2026device pma181d agoBoston Scientific — INGEVITY™ MRI/ model 7731; INGEVITY™ MRI/ model 7732; INGEVITY™ MRI/ model 7735; INGEVITY™ MRI/ model 7736; INGEVITY™ MR (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
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    $MDT90.76+0.09%
    $BSX51.42+0.45%
    $LUNG1.3700-3.52%
    $FRTRY
    $MMSI91.20+0.10%
    $BSX51.42+0.45%
    $HRMY39.77+0.63%
    $MMSI91.20+0.10%
    $VYCO0.06600.00%
    $FRTRY
    $MDT90.76+0.09%
    $BSX51.42+0.45%